UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038097 |
|---|---|
| Receipt number | R000043422 |
| Scientific Title | The effect of 12-week intake of NMN on the sleep and fatigue of community-dwelling older adults |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2020/12/11 10:07:41 |
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Basic information
Public title
The effect of 12-week intake of NMN on the sleep and fatigue of community-dwelling older adults
Acronym
The effect of NMN intake on sleep and fatigue
Scientific Title
The effect of 12-week intake of NMN on the sleep and fatigue of community-dwelling older adults
Scientific Title:Acronym
The effect of NMN intake on sleep and fatigue
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of daily intake of NMN for 12 weeks on sleep, fatigue and mental health with community-dwelling older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of Pittsburgh Sleep Quality Index(PSQI), Visual Analogue Scale(VAS) of evaluating physical fatigue and eye strain, Geriatric depression scale(GDS), Sense of Coherence(SOC) using questionnaires
Key secondary outcomes
1) Physical performance tests: Grip strength, Five times sit to stand, Timed up and go, 5m habitual walk
2) Cognitive functions: Trail Making Peg, Five cognitive function test(attention, verbal memory, visuospatial cognition, word fluency, associate learning)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of NMN (253.8mg) every morning for 12 weeks (from getting up to 12 am)
Interventions/Control_2
Intake of NMN (253.8mg) every afternoon for 12 weeks (from getting up to 12 am (from 6pm to before bedtime)
Interventions/Control_3
Intake of placebo every morning for 12 weeks (from getting up to 12 am)
Interventions/Control_4
Intake of placebo every afternoon for 12 weeks (from 6pm to before bedtime)
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects with the capacity to participate the study-related briefing sessions, examinations and measurements in University of Tsukuba by themselves
2) Subjects without dementia, need for long-term care service, sleep disorders or regular intake of sleeping drugs(more than once a week) depression or regular intake of anti-depressants(more than once a week)
3) Subjects with a thorough understanding of this study, and voluntary consent
Key exclusion criteria
1) Subjects with a regular intake of sleeping drugs or anti-depressants(more than once a week)
2) Subjects with an average intake of caffeine more than 400mg per day
3) Subjects with intake of supplements, nutrition drinks or energy drinks that contain NMN or niacin (Vitamin B3, nicotinamide, nicotinic acid amide)
4) Subjects with allergies to supplements, nutrition drinks or energy drinks that contain NMN or niacin(Vitamin B3, nicotinamide, nicotinic acid amide)
5) Subjects diagnosed with chronic fatigue syndrome, sleep disorders(insomnia), mental disorders such as depression, or alcoholism and under medical treatment
6) Subjects who correspond to Not at all in category of fatigue, poor sleep or stress based on 5 level evaluation (Not at all, Slightly, Moderately, Very much, Extremely)
7) Subjects who are involving in other clinical experiments currently or having participated any other clinical experiments in the past 3 months
8) Subjects excluded as inappropriate participants by the lead principal investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba
TEL
029-859-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Mijin |
| Middle name | |
| Last name | Kim |
Organization
University of Tsukuba
Division name
Industry-University Collaboration R&D Center for Tailor-Made QOL
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba
TEL
029-859-2744
Homepage URL
mjmj0816@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-2571
takano.nobuo.ka@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
108
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043422
